A Single-center, Prospective, Single-arm Observational Study of Romiplostim N01 Combined with Standard Immunosuppressive Therapy in Patients with Aplastic Anemia (AA)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600120617

Enrollment

Unknown

Registered

2026-03-17

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aplastic Anemia

Interventions

Observation Group:None

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Adult Patients with Aplastic Anemia (AA) Receiving Romiplostim N01 Combined with Standard Immunosuppressive Therapy in Routine Clinical Practice;

Exclusion criteria

Exclusion criteria: 1.Situations deemed inappropriate for participation in this clinical study by investigator assessment;

Design outcomes

Primary

Measure	Time frame
Complete Hematologic Response Rate (CR) at Week 14 of Treatment;	—

Secondary

Measure	Time frame
Adverse Events, Laboratory Tests, Vital Signs, Electrocardiogram (ECG) Recordings, and Physical Examinations, etc.;Partial Hematologic Response Rate (PR) and Overall Hematologic Response Rate (OR) at Week 14 of Treatment;Hematologic Response Rates (CR, PR, and OR) at Week 27 of Treatment;Changes in Platelet Count, Hemoglobin, Absolute Neutrophil Count (ANC), and Reticulocyte Count from Baseline During Patients’ Follow-up Hospital Visits in Real-world Clinical Practice;Proportion of Patients with Cumulative Blood Transfusion Requirement, Total Volume of Platelet Transfusion, Total Volume of Red Blood Cell Transfusion, and Proportion of Patients with Disease Progress;Time to First Occurrence of Hematologic Response (CR or PR);	—

Measure

Time frame

Adverse Events, Laboratory Tests, Vital Signs, Electrocardiogram (ECG) Recordings, and Physical Examinations, etc.;Partial Hematologic Response Rate (PR) and Overall Hematologic Response Rate (OR) at Week 14 of Treatment;Hematologic Response Rates (CR, PR, and OR) at Week 27 of Treatment;Changes in Platelet Count, Hemoglobin, Absolute Neutrophil Count (ANC), and Reticulocyte Count from Baseline During Patients’ Follow-up Hospital Visits in Real-world Clinical Practice;Proportion of Patients with Cumulative Blood Transfusion Requirement, Total Volume of Platelet Transfusion, Total Volume of Red Blood Cell Transfusion, and Proportion of Patients with Disease Progress;Time to First Occurrence of Hematologic Response (CR or PR);

—

Countries

China

Contacts

Public ContactLina Zhang

Henan Cancer Hospital

zhangy741104@163.com+86 371 65587803

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026